Welcome
Your Trusted Advisor -Consulting Chief Scientific Medical Officer
Transform Modern Medicine Development:
The 21st Century Biology-based Medicine
Unique Approach to Modern Medicine Development
Unique Clinical Data Expertise
Unique Clinical Data Expertise
Unique Clinical Data Expertise
Use Synthetic Thinking to Intercept Clinical Data: Seeing the Elephant.
R&D Clinical Pipeline Strategy
Unique Clinical Data Expertise
Unique Clinical Data Expertise
Conduct Strategic Review to Build Asset MoA-Disease Maps.
Intangible Assets
Unique Clinical Data Expertise
Intangible Assets
Proven Track Record of Success.
Intangible Assets and Know-How.
Visionary Leader, Problem Solver, Passionate Do'er.
Guiding Principle
Guiding Principle
Guiding Principle
If we do know the science around the target or drug, and have a deep understanding of the disease biology, along with expertise of dosing & pharmacology, we can achieve >90% success.
The problem is that most people don’t know what they don’t know, thus fail to see the forest for the trees.
Goals
Guiding Principle
Guiding Principle
Unique Approach to
1. Solve the Most Difficult Problem in the Development of Modern Medicine: 90% Failure.
2. Find the Right Drug for the Right Patient at the Right Time with the Right Dose!
Core Competences
Guiding Principle
Core Competences
Tactic: MoA-Disease Match Precision.
1. Retina & Glaucoma Specialty Care and Cornea & Ocular Surface Diseases.
2. Stem Cell & Gene Therapy, Drug and Combination Product Development.
PHOTO GALLERY
Background and Examples of Success
Dr. Tina Guanting Qiu (MD, PhD) is a highly accomplished Biopharma physician executive with 25-year U.S. and international experience in global Pharma, biotech, device and strategic consulting firm. She has acquired top tier know-how skills of product development with proven track records of solving critical problem, turning around situation and maximizing development outcomes that are translated into shareholder value, capital saving and revenue profit. Leadership roles in scientific medical development, business and regulatory strategies, entrepreneurial startups, and external KOLs and shareholder relations.
Dr. Qiu has held position with increased importance at GSK, Inotek Pharma and Sucampo Pharma, and advised senior executives at R&D Clinical Regulatory Commercial Business and Investment. She obtained her Medical Degree with Distinguished Honor at Nanchang University, and Doctorate of Ophthalmology at National Sun Yat-sen University in collaboration with University of Pennsylvania, followed by postdoctoral trainings at Boston University and University Southern California. She lectured widely across the globe and has been featured in “Scientific America” and National Eye Research Center, UK. She is a lawful US Citizen since 2011.
Industry Background: Astellas Pharma, Sanofi Aventis, GlaxoSmothKline, Inotek Pharma, Sucampo Pharma, LambdaVision, Ocular Therapeutics, Spiral Therapeutics, Gerson Lehmarn Group.
Retina Domain:
- Consulted for a phase 2b/3 retina gene therapy project determining Go/No-Go decision after $26M, 7- year investment, established standards for gene therapy on rare disease clinical trials. Suggested “pause/repair”, saving millions of dollars and becoming a standard.
- As ophthalmic medical expert spearheaded for Japanese first retina gene therapy optogenetic project for end-stage retinitis pigmentosa (Ph 1/2), generated significant scientific impact in Japan UK and US.
- Ophthalmology Clinical Expert advised on the first generation hESC-RPE transplant: Phase 1/2 DSMB review & imaging data analysis with pioneering vision in defining a strategic road-map for hESC-RPE cell validation and development via adaptive clinical trials.
- Innovative Retina Surgeon: 1) Advising Clinical Gene Therapy and Subretina Stem Cell Transplant on sub retinal surgical delivery parameter design & bleb fashion. 2) Created novel sub retina surgical SOP for cutting-edge protein implant (artificial retina), saved the entire budget for surgical tool making. 3) Broke the records of out-performing most delicate sub retina implant surgeries in large animal model.
Glaucoma Domain:
- Within 3 days, created best in class new product lines with $20B market cap, which could change ophthalmic drug delivery paradigm in decade to come, saving multi-million dollars in R&D budgets due to intangible assets & know-how (unmatched speed & quality in the deliverables: 20 pages plus 33 slides in 32hrs).
- Alcon/ASCRS Taskforce on Cypass withdrawal root analysis and risk-mitigation strategy (top tier expert nailed down the real killer-30" spot on the problem).
- 5 months, helped turnaround Inotek Pharma via repurpose and reposition strategy: used evidence-based approach to create multi-million $ R&D pipelines at no cost and built win-win clinical medical strategy, which had contributed to hundreds million $ finance success upon IPO -unprecedented success.
- 3 months as scientific backbone helped bring a "dead" drug (Rescula) back to the market, first "discovered" Rescula as a "retina" drug other than glaucoma IOP lowering drug (Novartis and R-Tech marketed).
Cornea & Ocular Surface Disorder :
- Support investors on due diligence & strategic review on AAV-gene therapy for cornea transplant and artificial cornea project, identified hidden traps which led to No-Go and avoided a bad deal.
- Provided strategic insight to investors on ophthalmic product portfolio, and advised clinical regulatory strategy (based on MoA), which helped catalyze the FDA approval of Lifitigrast (dry eye).
OTI Introductory Video:
https://www.dropbox.com/s/hho7j5mzfv3drrj/Re-recorded%20trainler%20OTI%20Intro.mp4?dl=0
OTI Scientific Gallery:
https://www.dropbox.com/sh/1s75lr4n4lvpjgr/AABWeprMbJvs3dDZuwIrixO3a?dl=0
Our Services
Retina Gene/Cell Therapy & Clinical Data Insight
IND and Phase 1-4 Clinical Protocol & Medical Strategy.
- Evidence-based Approach to Clinical Data Analysis;
- Biology-based Insight to Subreitnal Bleb Design & Procedure SOP.
R&D Strategic Review
Conduct Strategic Review to Build Asset MoA-Disease "Map" Franchise Indication & New Product Planning
Product Development Path-Finding to IND Enabling Stage
(up to 80% saving)
IND Package Review & "Must-Have"
Commercial Medical Affairs
KOLs Development & SAB Relations
Strategic Scientific Communication
Product Launch Taskforce
Product Medical Strategy
Medical Education & Trainings
Our Partners
Contact Us
Please send us a message for an appointment.
Ophthalmic Therapeutic Innovation MA
Hours
Monday - Saturday: 8:00am - 5:00pm
Sunday: Closed
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